(136 days)
The Implex Revision Hedrocel® Patella is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, 5) treatment of fractures that are unmanageable using other techniques, and 6) complications from failed prosthesis.
This device is intended for use with bone cement and supplemental fixation by means of suture attachment. Supplemental suture attachment may be used in cases where additional device support can be obtained.
The Revision Hedrocel® Patella is a modular porous backed patella consisting of a Hedrocel® Patellar Backing with titanium alloy suture ring and the current commercially available Continuum® Patella. The Revision Hedrocel® Patella provides the surgeon a method for augmenting defects in the patella typically encountered during revision surgery of the knee.
The provided text describes a 510(k) premarket notification for a medical device, the Implex Revision Hedrocel® Patella. The information focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, many of the requested details about acceptance criteria, device performance results, sample sizes for test/training sets, expert qualifications, ground truth establishment, and MRMC studies are not present in the provided document. This is common for 510(k) submissions, which often rely on similarities to previously cleared devices and existing performance data for those predicate devices.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
1. Table of acceptance criteria and the reported device performance
This information is not explicitly stated in the document as a set of defined acceptance criteria with corresponding performance metrics from a new study. The submission relies on "similarities in design" and "performance testing submitted in K882322 and K971879, and Hedrocel® materials' data found in MAF #920" of predicate devices to conclude that the new device "will perform as intended."
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable/Not provided. No new performance study or test set data is described for the Implex Revision Hedrocel® Patella itself in this document. The submission relies on data from predicate devices.
- Data provenance: Not applicable/Not provided for a new test set for this device. The referenced predicate device data (K882322, K971879, MAF #920) would have their own provenance, but these details are not in the current document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No new performance study requiring expert adjudication to establish ground truth for a test set is described.
4. Adjudication method for the test set
Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical implant device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical implant device, not an algorithm.
7. The type of ground truth used
Not applicable/Not provided for this device's performance. The submission makes a "substantial equivalence" claim based on:
- "materials, design and articulating surface geometry" being "similar and/or identical" to predicate devices.
- Performance data of predicate devices (K882322 and K971879) and "Hedrocel® materials' data found in MAF #920."
The "ground truth" here is essentially the prior FDA clearance and established performance of the predicate devices and materials.
8. The sample size for the training set
Not applicable/Not provided. This device is not an AI algorithm that undergoes training.
9. How the ground truth for the training set was established
Not applicable/Not provided.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.